CBER News 12/3 through 12/7

New regulatory decisions, manufacturing partnerships, and financing pressures are reshaping access, supply, and development pathways for emerging advanced therapies.

Caribou is halting vispa-cel and CB-011, allogeneic CAR-T therapies that showed up to 92% response rates, citing a difficult financing environment.

Celltrion USA's Omlyclo, the first interchangeable biosimilar to Xolair, reaches the U.S. market across four allergic and inflammatory indications.

Alvotech turns to a CDMO's 40,000-liter Syracuse facility for biosimilar drug substance as it expands its manufacturing network.

AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.

New data and partnerships are advancing brain-penetrant enzyme therapy, targeted antibodies, flexible obesity dosing, and frontline lymphoma treatment strategies.

Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.

Part 2 of the VK2735 maintenance study tests whether daily or weekly oral tablets can hold weight loss first achieved with weekly subcutaneous injections.